by Willie McKinney, Ph.D., DABT
Oscar Wilde once defined a cynic as a person “who knows the price of everything and the value of nothing.”
Unfortunately, that epigram may also fit some companies seeking FDA market authorization for new tobacco products. They worry about research budgets but miss the value and benefits of proactively generating bridging data. The right bridging strategy may require a small investment, but it can save you millions of dollars in research costs. (Now do I have your attention?)
As smokers displace combustible cigarettes with new tobacco product alternatives, scientists in regulatory agencies, industry and academia need information on the long-term health effects of the alternative products. The gold standards– for manufacturers with unlimited budgets and no time pressure–are long-term clinical or epidemiological studies that demonstrate that the product is appropriate for the protection of public health (APPH). That ideal is often out of reach for typical applicants. A more-practical approach is to build a bridge: to design a set of smaller studies that will demonstrate a connection between your product and a body of existing (and expensive) published research data.
In fact, the FDA has encouraged this approach:
“If you feel that literature reviews may be an appropriate means for satisfying the requirements of section 910(b)(1)(B), please explain clearly how an adequate comparison (e.g., bridging) can be made between the products analyzed in the published material and the specific product that is the subject of your PMTA.”
In other words, if you can adequately link new research on your product to an existing product on which there is substantive research–establish appropriate equivalency– you can incorporate that existing research into your application. That modest investment unlocks a treasure trove of data. That’s the core of your bridging strategy.
Step One: Ask the Right Question
What critical questions might a bridging strategy address? Choosing the right question(s) for your product is step one. For example:
- How can I demonstrate that I do not need to test all products in my portfolio if my tobacco products are the same except for the nicotine concentration?
- How do I demonstrate that my new tobacco product is similar to a tobacco product that has been tested in a long-term clinical study?
- How do I demonstrate that I do not need to do all the tests suggested in the FDA guidance if I only change one component of my device? (And which ones might I skip?)
- How do I demonstrate that my new tobacco product performs similarly to market authorized products?
The bridging studies that answer your question(s) are paradoxical. You’re strategically generating data to demonstrate that you don’t need to generate data. Instead, much like a real estate investor who uses OPM (other people’s money) to purchase an apartment building, you’re making the case for using other people’s data to support your claim. This will reduce application preparation time and save you several million dollars in research costs.
Step Two: Create the Leverage
The bridging goal determines the testing approach. For example, we’ve designed efficient and cost-effective research protocols that tested the upper and lower limits of a subset of product features. Those bridging studies obviated the need to test each incremental change within those boundaries, saving what might have been thousands of hours of work.
For another client, our goal was to show that the similarity of the aerosol chemistry profile and topography of a new and existing product negated the need for extensive new studies on long-term health effects. By designing and executing a smaller bridging study, we demonstrated the validity of using data that were already peer-reviewed and published–and that we knew would help make our case. This reduced uncertainty, increased speed to market, and saved money.
Showing similarity to a market-authorized product is likely to provide the best return on investment. We used aerosol chemistry and consumer use information to bridge between an FDA authorized product and a new tobacco product. This bridging data demonstrated that the scientific data supporting a market-authorized product applies to the new tobacco product. This bridge makes it easier for the FDA see new tobacco products as APPH.
When correctly planned and executed, bridging is a valuable tool that helps companies better understand their products while also sparing time and expense preparing a PMTA. Good investment?